Appendix 8.5.2.2
Criteria for Identifying
Patients with Potentially Clinically Significant Changes in Hematology Variables
|
Hematology Test |
Gender |
Ages |
Low |
High |
|
Hemoglobin |
M |
<59 yrs |
<10.2 g/dL |
>21.7 g/dL |
|
F |
<9.3 g/dL |
>19.7 g/dL |
||
|
M |
≥59 yrs |
<10.0 g/dL |
>20.4 g/dL |
|
|
F |
<9.2 g/dL |
>19.0 g/dL |
||
|
MCV |
M |
` |
<71 fL |
>106 fL |
|
F |
<71 fL |
>108 fL |
||
|
M/F |
≥59 yrs |
<72 fL |
>110 fL |
|
|
WBC |
M/F |
<59 |
<3.05 X 103/uL |
>16.1 X 103/uL |
|
F |
≥59 yrs |
<2.8 X 103/uL |
>15.8 X 103/uL |
|
|
Neutrophils |
M/F |
All |
<20% |
>85% |
|
Lymphocytes |
M/F |
All |
<5% |
>60% |
|
Moncytes |
M/F |
All |
-- |
>15% |
|
Eosinophils |
M/F |
All |
-- |
>10% |
|
Basophils |
M/F |
All |
-- |
>15% |
|
Platelets |
M/F |
All |
<104 x 103/uL |
>591 X 103/uL |
|
Vital
Sign |
Low |
High |
|
Systolic
Blood Pressure |
≤90 mm Hg with
decrease ≥20 |
≥180 mm Hg with
increase ≥20 |
|
Diastolic
Blood Pressure |
≤50 mm Hg with
decrease ≥15 |
≥105 mm Hg with
increase ≥15 |
|
Pulse |
≤50 bpm with
decrease ≥15 |
≥180 bpm with
increase ≥15 |
|
Weight |
Loss ≥ 5 lbs. |
Gain ≥ 5 lbs. |
Bupropion
Sustained-Release Clinical Review 62
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